Breast NeoplasmsNCT01661023
The Ghana Breast Health Study
An observational study of Breast Neoplasms, run by National Cancer Institute (NCI) at 2 sites in Ghana.
Trial summary
Background: Breast cancer is becoming more common in Africa. A higher number of cases appear in women under age 35 than in the developed world. However, little is known about the factors that may contribute to breast cancer in Africa. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 4,241 participants
- Where
- 2 sitesGhana
- Study dates
- 19 Jul 2012to 16 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The source of breast cancer cases included the two largest teaching/cancer treatment hospitals in the country, Korle Bu Teaching Hospital in Accra and Komfo Anoyke Teaching Hospital in Kumasi, as well as Peace and Love Hospital, a private hospital in Kumasi that specializes in breast cancer care and diagnoses and treats a large number of breast cancer patients. Eligibility criteria for study cases included being recommended for a biopsy given lesions suspicious of malignancy or presenting at a @@@study hospital for treatment of pathologically documented breast cancers diagnosed within the preceding year.Controls were selected from women in the catchment area of the hospitals using data from the 2010 Census, matched on age and geographical area to the the cases.@@@@@@
- ELIGIBILITY CRITERIA:
Eligible for inclusion as cases in this study will be women 18-74 years of age who have been residents of defined catchment areas surrounding the two cities for at least one year s time and who are either diagnosed at the study hospitals within the past year (KBTH, KATH, and PLH) or referred there for clinical care. The catchment area in Accra will consist of 10 districts in Greater Accra (Accra Metropolitan, Adenta, Tema, Ashaiman, Ga East, Ga West, Ledzokuku-Krowor, Weija (Ga South), Dangbe East, Dangbe West), two in the Eastern region (Suhum Kraboa Coaltar, Akwapim South) and one in the Central region (Awutu Senya). In Kumasi, the catchment area will consist of 7 districts surrounding KATH and PLH (Atwima Kwanwoma, Atwima Nwabiagya, Bosumtwi, Ejisu Juaben, Afigya Kwabre, Kwabre, and Kumasi Metropolitan).
Trial locations and contacts
2 sites in 1 country.
Ghana2 sites
University of Ghana
Accra
Kwane Nkrumah University of Science and Technology
Kumasi
About this study
Official title: A Multidisciplinary Study of Breast Cancer in Ghana
Background:
- Breast cancer is becoming more common in Africa. A higher number of cases appear in women under age 35 than in the developed world. However, little is known about the factors that may contribute to breast cancer in Africa. Researchers want to collect information from female patients in teaching hospitals in Accra and Kumasi, Ghana and to compare this information with that obtained from healthy women in the general population. These two hospitals treat most breast cancers in Ghana. The data will provide information regarding factors that predispose to the development of breast cancer among women in Ghana.
Read more
Objectives:
- To identify and study breast cancer risk factors in women in Ghana.
Eligibility:
- Women between 18 and 74 years of age who are diagnosed with breast cancer.
- Participants will come from teaching hospitals in Accra and Kumasi, Ghana. Women without breast cancer will be identified from the 2010 Ghanaian Census for comparison purposes
Design:
- Participants will answer questions about their health and lifestyle.
- Height, weight, and waist/hip measurements will be collected.
- Blood and saliva samples will be collected.
- Participants will be given a collection kit to collect a stool sample.
- Treatment will not be provided as part of this study.
Read the detailed description
Breast cancer is becoming a more common disease in Africa, with a high proportion of cases developing among women under age 50. Despite this, there is scant information on predisposing factors in African populations. We are proposing a multidisciplinary case-control study at three hospitals in Accra and Kumasi that treat the majority of breast cancers in Ghana. We have begun this investigation as a pilot endeavor and are seeking approval for continuation into a full-scale effort, which over the two years following the pilot will result in a total of approximately 2,000 interviewed cases and 2,000 population controls. Tumor tissue samples are being sought from cases in order to classify them into subtypes (including triple negative tumors, which predominate among young African women). A detailed questionnaire is being administered in hospital and anthropometry measurements are being taken. Additionally, subjects are being asked to donate blood, saliva, and stool samples for assessment of genetic and other biologic markers. Similar materials are being collected from population controls. In addition to providing unique data relevant for improving prevention activities, this study will build capacity for additional research activities in Ghana.
- Conditions
- Breast Neoplasms
- Keywords
- Breast Cancer, Epidemiology
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Cancer
Pathologically confirmed diagnosis of breast cancer
Measured: Within one year of diagnosis
Secondary outcomes (1)
Benign breast disease
Measured: At biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study start19 Jul 2012
- Primary completion25 Apr 2016
- Study completion16 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4,241 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Montserrat Garcia-Closas, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661023
- Sponsor's protocol ID
- 999912174
- Other IDs
- 12-C-N174
- Status last verified
- Apr 2020
- First submitted
- 7 Aug 2012
- Last updated
- 20 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huo D, Ikpatt F, Khramtsov A, Dangou JM, Nanda R, Dignam J, Zhang B, Grushko T, Zhang C, Oluwasola O, Malaka D, Malami S, Odetunde A, Adeoye AO, Iyare F, Falusi A, Perou CM, Olopade OI. Population differences in breast cancer: survey in indigenous African women reveals over-representation of triple-negative breast cancer. J Clin Oncol. 2009 Sep 20;27(27):4515-21. doi: 10.1200/JCO.2008.19.6873. Epub 2009 Aug 24.
PubMed 19704069Akarolo-Anthony SN, Ogundiran TO, Adebamowo CA. Emerging breast cancer epidemic: evidence from Africa. Breast Cancer Res. 2010 Dec 20;12 Suppl 4(Suppl 4):S8. doi: 10.1186/bcr2737. No abstract available.
PubMed 21172092Walker AR, Adam FI, Walker BF. Breast cancer in black African women: a changing situation. J R Soc Promot Health. 2004 Mar;124(2):81-5. doi: 10.1177/146642400412400212.
PubMed 15067980
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidisciplinary Study of Breast Cancer in Ghana
- ClinicalTrials.gov ID
- NCT01661023
- Acronym / sponsor ID
- 999912174
- Conditions
- Breast Neoplasms
- Keywords
- Breast Cancer, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,241 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 19 Jul 2012 (actual)
- Primary completion
- 25 Apr 2016 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Breast cancer is becoming more common in Africa. A higher number of cases appear in women under age 35 than in the developed world. However, little is known about the factors that may contribute to breast cancer in Africa. Researchers want to collect information from female patients in teaching hospitals in Accra and Kumasi, Ghana and to compare this information with that obtained from healthy women in the general population. These two hospitals treat most breast cancers in Ghana. The data will provide information regarding factors that predispose to the development of breast cancer among women in Ghana.
Objectives:
- To identify and study breast cancer risk factors in women in Ghana.
Eligibility:
- Women between 18 and 74 years of age who are diagnosed with breast cancer.
- Participants will come from teaching hospitals in Accra and Kumasi, Ghana. Women without breast cancer will be identified from the 2010 Ghanaian Census for comparison purposes
Design:
- Participants will answer questions about their health and lifestyle.
- Height, weight, and waist/hip measurements will be collected.
- Blood and saliva samples will be collected.
- Participants will be given a collection kit to collect a stool sample.
- Treatment will not be provided as part of this study.
Detailed description
Breast cancer is becoming a more common disease in Africa, with a high proportion of cases developing among women under age 50. Despite this, there is scant information on predisposing factors in African populations. We are proposing a multidisciplinary case-control study at three hospitals in Accra and Kumasi that treat the majority of breast cancers in Ghana. We have begun this investigation as a pilot endeavor and are seeking approval for continuation into a full-scale effort, which over the two years following the pilot will result in a total of approximately 2,000 interviewed cases and 2,000 population controls. Tumor tissue samples are being sought from cases in order to classify them into subtypes (including triple negative tumors, which predominate among young African women). A detailed questionnaire is being administered in hospital and anthropometry measurements are being taken. Additionally, subjects are being asked to donate blood, saliva, and stool samples for assessment of genetic and other biologic markers. Similar materials are being collected from population controls. In addition to providing unique data relevant for improving prevention activities, this study will build capacity for additional research activities in Ghana.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source of breast cancer cases included the two largest teaching/cancer treatment hospitals in the country, Korle Bu Teaching Hospital in Accra and Komfo Anoyke Teaching Hospital in Kumasi, as well as Peace and Love Hospital, a private hospital in Kumasi that specializes in breast cancer care and diagnoses and treats a large number of breast cancer patients. Eligibility criteria for study cases included being recommended for a biopsy given lesions suspicious of malignancy or presenting at a @@@study hospital for treatment of pathologically documented breast cancers diagnosed within the preceding year.Controls were selected from women in the catchment area of the hospitals using data from the 2010 Census, matched on age and geographical area to the the cases.@@@@@@
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Breast Cancer
Time frame: Within one year of diagnosis
Pathologically confirmed diagnosis of breast cancer
1 secondary outcome
Benign breast disease
Time frame: At biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Background: PubMed 19704069Huo D, Ikpatt F, Khramtsov A, Dangou JM, Nanda R, Dignam J, Zhang B, Grushko T, Zhang C, Oluwasola O, Malaka D, Malami S, Odetunde A, Adeoye AO, Iyare F, Falusi A, Perou CM, Olopade OI. Population differences in breast cancer: survey in indigenous African women reveals over-representation of triple-negative breast cancer. J Clin Oncol. 2009 Sep 20;27(27):4515-21. doi: 10.1200/JCO.2008.19.6873. Epub 2009 Aug 24.
- Background: PubMed 21172092Akarolo-Anthony SN, Ogundiran TO, Adebamowo CA. Emerging breast cancer epidemic: evidence from Africa. Breast Cancer Res. 2010 Dec 20;12 Suppl 4(Suppl 4):S8. doi: 10.1186/bcr2737. No abstract available.
- Background: PubMed 15067980Walker AR, Adam FI, Walker BF. Breast cancer in black African women: a changing situation. J R Soc Promot Health. 2004 Mar;124(2):81-5. doi: 10.1177/146642400412400212.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montserrat Garcia-Closas, M.D. principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by National Cancer Institute (NCI) at 2 sites in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Cancer (time frame: Within one year of diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01661023, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020; AzTrials last refreshed its copy on 2 Nov 2026.